Second low-dose estrogen-MPA combo approved.(Two Prempro Formulations)

The Food and Drug Administration has approved a second low-dose formulation of the conjugated estrogen-medroxyprogesterone acetate combination.

Last month the FDA approved a Prempro formulation (0.3 mg of conjugated estrogens and 1.5 mg of medroxyprogesterone acetate) for the treatment of moderate to severe menopausal symptoms and the prevention of postmenopausal osteoporosis.

The FDA also expanded the approved uses for another low-dose Prempro formulation (0.45 mg of estrogen and 1.5 mg of medroxyprogesterone) for postmenopausal osteoporosis prevention; it was approved earlier this year for the treatment of menopausal symptoms.

Wyeth, the manufacturer of both products, said that Prempro 0.45/1.5 is now available and that Prempro 0.3/1.5 would be available in "late 2003."

Two other Prempro formulations are already on the market. The formulation containing 0.625 mg of conjugated estrogens and 2.5 mg of medroxyprogesterone was associated with an increased risk of stroke, myocardial infarction, invasive breast cancer, and cardiovascular disease in the Women's Health Initiative study, resulting in early termination of that arm of the study last summer. Prempro 0.625/5.0 is also available.

All four doses were investigated in the Women's Health, Osteoporosis, Progestin, and Estrogen (HOPE) study of healthy postmenopausal women, 40-65 years of age, results of which were published 2 years ago. The low-dose formulations had beneficial effects on menopausal symptoms comparable ...